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In Vivo Real-time Detection of Circulating Melanoma Cells


N/A
18 Years
80 Years
Not Enrolling
Both
Melanoma

Thank you

Trial Information

In Vivo Real-time Detection of Circulating Melanoma Cells


Study Population: Approximately 80 subjects will be consented in order to achieve an
enrollment goal of 75 subjects at this institution in three cohorts as follows:

1. Cohort #1 will consist of fifteen healthy control subjects, ten of whom will be
Caucasian and five of whom will be African-American. Subjects in cohort #1 will be used
to address the calibration goal of Specific Aim #1.

2. Cohort #2 will consist of 30 subjects who have advanced-stage melanoma will be
recruited from the Medical Oncology clinic at UAMS, where advanced stages are defined
as Stages III or IV. Subjects in cohort #2 will be used to address the validation goal
of Specific Aim #2. Approximately half of the 30 advanced-stage subjects will be Stage
III and the other half will be Stage IV.

3. Cohort #3 will consist of 30 subjects with early-stage melanoma will be recruited from
the Surgical Oncology clinic at UAMS, where early stages are defined as Stages I or II.

Subjects in cohort #3 will be used to address the detection goal of Specific Aim #3.
Approximately 10 of the 30 early-stage subjects will be Stage I and approximately 20 will be
Stage II.


Inclusion Criteria:



- Age 18 to 80 years

- Histological documented diagnosis of melanoma

- Signed informed consent form approved by the University of Arkansas for Medical
Sciences (UAMS) Institutional Review Board (IRB)

- Must be able to sit still for 90 minutes

Exclusion Criteria:

- Active infection

- Current and significant medical or surgical condition as determined by the
Investigator

- Diagnosis or evidence of organic brain syndrome

- Pregnancy or breastfeeding

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Number of participants that possess circulating tumor cells.

Outcome Time Frame:

14-21 days

Safety Issue:

No

Principal Investigator

Laura Hutchins, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas

Authority:

United States: Institutional Review Board

Study ID:

133965

NCT ID:

NCT01776905

Start Date:

February 2013

Completion Date:

Related Keywords:

  • Melanoma
  • Melanoma
  • Cancer
  • Melanoma

Name

Location

University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205